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腹主动脉瘤腔内修复术的临床效果:与开放修复术的7年同期比较

Clinical effect of abdominal aortic aneurysm endografting: 7-year concurrent comparison with open repair.

作者信息

Cao Piergiorgio, Verzini Fabio, Parlani Gianbattista, Romano Lydia, De Rango Paola, Pagliuca Valentino, Iacono Gustavo

机构信息

Unit of Vascular Surgery, Policlinico Monteluce, Azienda, Ospedaliera di Perugia, Perugia 06122, Italy.

出版信息

J Vasc Surg. 2004 Nov;40(5):841-8. doi: 10.1016/j.jvs.2004.08.040.

Abstract

OBJECTIVE

We compared the effectiveness and clinical outcome of open repair versus endovascular aortic aneurysm repair (EVAR) in achieving prevention of abdominal aortic aneurysm (AAA)-related death and graft-related complications.

METHODS

Over 7 years from 1997 to 2003, 1119 consecutive patients underwent elective treatment of infrarenal AAAs, 585 with open repair and 534 with EVAR. Patients were regularly followed up at 1, 6, 12 months, and every 6 months thereafter, in EVAR group, and at 3 and 12 months, and yearly thereafter after open repair. Preoperative, intraoperative, and follow-up data were stored in a prospective database.

RESULTS

Median follow-up was similar in the 2 groups: 33 months (interquartile range [IQR], 13-50 months) in the EVAR group vs 35 months (IQR, 15-54 months) in the open repair group. EVAR group patients were older than patients in the open repair group: 73 years vs 72 years (P = .04). There were statistical significant differences between the EVAR group and the open repair group with respect to AAA median diameter (52 mm vs 56 mm), coronary disease rate (46% vs 37%; P = .001), pulmonary disease rate (56% vs 38%; P < .0001), and American Society of Anesthesiologists IV score rate (16% vs 6%; P < .0001). Thirty-day mortality in the EVAR group was 0.9% (5 of 534 patients), compared with 4.1% (24 of 585 patients; P = .001) in the open repair group, and major morbidity was 9.1% (49 of 534 patients) vs 18.6% (109 of 585 patients; P < .0001), respectively. The incidence of secondary procedures in the EVAR group was 15.7%, compared with 3% in the open repair group (P < .0001). There were no deaths related to secondary procedures in either group. Six AAAs (1.1%) ruptured after EVAR, 3 of which were fatal; in the open repair group 1 patient (0.2%) underwent successful repeat operatation to treat iliac pseudoaneurysm rupture 5 years after the original procedure. Kaplan-Meier estimates for freedom from aneurysm-related death at 84 months were 97.5% in the EVAR group and 95.9% in the open repair group (log rank test, P = .008). Kaplan-Meier survival estimates at 84 months were 67.1% in the open repair group and 66.9% in the EVAR group (P = NS). At the same interval the risk for secondary procedures was 49.4% for the EVAR group and 7.1% for the open repair group. Of the 11 variables analyzed with logistic analysis, open surgery (hazard ratio [HR], 11; 95% confidence interval [CI], 2.5-54.2; P = .002), American Society of Anesthesiologists IV score (HR, 7.1; 95% CI, 2.7-18.8; P = .0001), and age (HR, 1.06; 95% CI, 1.04-1.13; P = .04) were positive independent predictors of perioperative mortality.

CONCLUSION

Our data suggest that at a maximum follow-up of 7 years, patients who undergo EVAR show lower perioperative and late aneurysm-related mortality compared with a younger and substantially healthier group of patients with aneurysms treated with open repair. The higher need for secondary procedures in the endovascular group did not affect superiority of the overall performance of EVAR in the early and late intervals.

摘要

目的

我们比较了开放修复术与血管腔内主动脉瘤修复术(EVAR)在预防腹主动脉瘤(AAA)相关死亡及移植物相关并发症方面的有效性和临床结果。

方法

1997年至2003年的7年间,1119例连续性患者接受了肾下腹主动脉瘤的择期治疗,其中585例行开放修复术,534例行EVAR。EVAR组患者在术后1、6、12个月及此后每6个月进行定期随访,开放修复组患者在术后3和12个月及此后每年进行随访。术前、术中和随访数据存储在前瞻性数据库中。

结果

两组的中位随访时间相似:EVAR组为33个月(四分位间距[IQR],13 - 50个月),开放修复组为35个月(IQR,15 - 54个月)。EVAR组患者比开放修复组患者年龄更大:73岁对72岁(P = 0.04)。EVAR组与开放修复组在AAA中位直径(52 mm对56 mm)、冠心病发生率(46%对37%;P = 0.001)、肺部疾病发生率(56%对38%;P < 0.0001)以及美国麻醉医师协会IV级评分发生率(16%对6%;P < 0.0001)方面存在统计学显著差异。EVAR组的30天死亡率为0.9%(534例患者中的5例),开放修复组为4.1%(585例患者中的24例;P = 0.001),主要并发症发生率分别为9.1%(534例患者中的49例)和18.6%(585例患者中的109例;P < 0.0001)。EVAR组二次手术的发生率为15.7%,开放修复组为3%(P < 0.0001)。两组均无与二次手术相关的死亡病例。6例AAA(1.1%)在EVAR术后破裂,其中3例致命;开放修复组有1例患者(0.2%)在初次手术后5年因髂动脉假性动脉瘤破裂接受了成功的再次手术。EVAR组在84个月时无动脉瘤相关死亡的Kaplan-Meier估计值为97.5%,开放修复组为95.9%(对数秩检验,P = 0.008)。开放修复组在84个月时的Kaplan-Meier生存估计值为67.1%,EVAR组为66.9%(P = 无显著差异)。在相同时间段内,EVAR组二次手术的风险为49.4%,开放修复组为7.1%。在通过逻辑分析的11个变量中,开放手术(风险比[HR],11;95%置信区间[CI],2.5 - 54.2;P = 0.002)、美国麻醉医师协会IV级评分(HR,7.1;95% CI,2.7 - 18.8;P = 0.0001)和年龄(HR,1.06;95% CI,1.04 - 1.13;P = 0.04)是围手术期死亡率的阳性独立预测因素。

结论

我们的数据表明,在最长7年的随访中,与接受开放修复术治疗的年龄更小且健康状况更佳的动脉瘤患者组相比,接受EVAR的患者围手术期及晚期动脉瘤相关死亡率更低。血管腔内组对二次手术的更高需求并未影响EVAR在早期和晚期整体表现的优越性。

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